The Swedish BioFINDER - Primary Care Study

NCT06120361 · tracked via the Priya Life Science Sweden tracker

Sponsor

Skane University Hospital

Phase

Observational

Started

2020-01-01

Last updated

2026-04-06

Condition(s) studied

Mild DementiaMild Cognitive ImpairmentSCDAlzheimer DiseaseLewy Body DiseaseFrontotemporal DegenerationVascular Dementia

Investigational drug(s) / intervention(s)

Plasma APS 2 scorePlasma p-tau217/np-tau217Plasma p-tau217Plasma neurofilament light (NfL)Plasma Ab42/Ab40MRI and CT of the brainDifferent cognitive tests

Plasma APS 2 score: APS 2 score (combination of ptau217/nptau217 and Ab42/Ab40). The cut off will be predefined. The samples will be analysed prospectively every two weeks.

Plasma p-tau217/np-tau217: The cut off will be predefined. The samples will be analysed prospectively every two weeks.

Plasma p-tau217: The cut off will be predefined. The samples will be analysed prospectively every two weeks.

Plasma neurofilament light (NfL): The cut off will be predefined. The samples will be analysed prospectively every two weeks.

Plasma Ab42/Ab40: The cut off will be predefined. The samples will be analysed prospectively every two weeks.

MRI and CT of the brain: Structural brain imaging

Different cognitive tests: Both standard paper-and-pen tests as well as digital cognitive tests will be evaluated.

Study summary

The overall aim of the study is to improve the diagnostic accuracy of AD and cognitive impairment in primary care settings to ensure better care and treatment as well as facilitate correct referrals to specialized memory clinics. The investigators will strive to recruit diverse and representative populations of patients with subjective cognitive decline (SCD), mild cognitive impairment (MCI) and mild dementia. The specific aims of the study are to:

1. Improve the detection of mild cognitive impairment (MCI) and dementia in primary care.
2. Develop and evaluate cognitive tests, blood-based biomarkers and brain imaging methods that are suitable for accurate and early diagnosis of Alzheimer's disease (AD) in primary care.
3. To prospectively validate plasma AD biomarkers for diagnosis of patients with cognitive symptoms who are evaluated in primary care.
4. Determine whether blood AD biomarkers improve patient management in primary care.

Eligibility

Sex

ALL

Min age

40 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. The patient seeks medical help because of cognitive symptoms experienced by the patient and/or informant OR The general practitioner suspects a progressive neurodegenerative disorder including, but not limited to, Alzheimer's disease, Lewy body disease, frontotemporal lobar degeneration or subcortical vascular cognitive impairment. 2. The main symptom is usually memory complaints, but could also be executive, visuo-spatial, language, or attention complaints. 3. Age ≥40 years 4. Subjective cognitive decline, mild cognitive impairment or mild dementia Exclusion Criteria: 1. Already diagnosed dementia 2. Significant unstable systemic illness or organ failure that makes it difficult to participate. 3. Current significant alcohol or substance misuse. 4. Refusing investigation at the Memory clinic 5. Cognitive impairment with acute onset due to stroke 6. The cognitive impairment can with certainty be explained by another condition or disease such as significant anemia, infection, severe sleep deprivation, psychotic disorder, moderate-severe depression, alcohol abuse etc.

Primary outcome measure(s)

Presence of brain AD pathology as determined by CSF AD biomarkers — At baseline (cross-sectional)
CSF Ab42/Ab40 and p-tau217

Trial sites (1)

Facility	City	Region	Status
Primary care centers in Region Skåne	Malmö	Sweden	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06120361 on ClinicalTrials.gov ↗ ← All trials in Sweden